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EFORT Reference in Orthopaedics and Traumatology

Wolfhart Puhl George Bentley Klaus-Peter GUnther Series Editors

Ceramic Surface Engineering of the Articulating Surfaces Effectively Minimizes Wear and Corrosion of Metal-on-Metal Hip Prostheses
Karel J. Hamelynck, David J. Woodnutt, Robin Rice, and Genio Bongaerts

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10.1
Introduction
The presence of high concentrations high non-physiologically of metal degradation particles within the hip joint and ions in the blood and

serum levels of cobalt and chromium

organs of patients after metal-on-metal (MoM) hip arthroplasty remains a matter of concern. These concerns lead to the question whether surgeons can continue to take the risk of using MoM prostheses knowing the potential for local and systematic complications, changes and or reactions of the materials performance in MoM bearing surface articulation. It is apparent that there is sufficient reason to try and solve these problems by reducing wear particles and corrosion of the bearing surface material. The question is "how?" Design factors have a great influence on wear of metal components, especially those factors which have an effect on lubrication [5]. Wear is minimal when fluid, like synovial fluid, separates the articulating surfaces. This situation is hard to achieve. More realistic is a combination of fluid film and mixed lubrication. In the mixed lubrication regime, the load is partially supported by a combination of contact with boundary lubricants (at the asperity tips) and by pressure developed in a fluid film that separates sorne, but not all, of the asperities of the articulating surfaces [5]. According to Jin et al, [6], optimal lubrication will occur and wear will be reduced when femoral head components with large diameters in combination with a smooth surface roughness and small diametrical clearances between the femoral and acetabular component are used.

KJ. Hamelynck(i2l) Van Breestraa t 52, 1071 ZR Amsterdam, The Netherlands e-mail: kjhamelynck@xs4all.nl G. Bongaerts
Orthopadisch Chirurg Gemeinschaftspraxis fur Orthopadie Ores, med, Jensen, Jensen, Bongaerts Rahlstedter Bahnhofstralie 7a D-22143, Hamburg, Germany

R. Rice Consultant Orthopaedic Surgeon Clinical Director, Trauma & Orthopaedics, Nevill Hall Hospital, Brecon Road, Abergavenny Gwent NP7 7EG, Wales, United Kingdom
0.1. Woodnutt Consultant Orthopaedic Surgeon Morriston Hospital, Heol Maes Eglwys Morriston, Swansea SA6 6NL, Wales, United Kingdom

K. Knahr (ed.), Tribology in Total Hip Arthroplasty, DOT: 10.1007/978-3-642-19429-0_10, © 2011 EFORT

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Various surgical reasons which may influence the wear of metal articulating surfaces in MoM hip arthroplasty have been identified. Femoral head components with diameters smaller than 46 mm, mostly used in women, demonstrated a revision rate much higher than femoral head components of a larger size [1]. Malposition of the acetabular component was found to be a cause of early failure [4, 7]. The common factor in these failures was lack of sufficient lubrication due to a too small a contact area or coverage angle, and edge loading of the cup, leading to excessive metal wear and subsequent negative local tissue reactions. When something was wrong within the joint, increase of metal ions in the blood was a common phenomenon [2]. Despite the fact that these surgical insufficiencies and design factors undoubtedly play

a role in excessive high metal ion levels in the blood and the frequency of soft tissue reactions near the hip joint, the bearing surface itself remains the key feature of the performance of metal- on-metal components. Surprisingly the role of the material of which all metal-onmetal prostheses are made, the cobalt-chromium-molybdenum alloy (CoCrMo), is not very clear. It is now generally accepted that alloys with higher carbon content are performing better than those with low-carbon content [9}. However, no differences were found, when various conditions from as-cast to. wrought, were tested [3]. Also the use of heat treatment, by which carbides are reduced in number and size, is controversial, A new approach to try and reinforce the articulating metal surfaces is surface engineering using a ceramic. The use of ceramic surface engineering in order to reduce wear and corrosion of metals is not uncommon in non-medical application. Ceramic surface engineering is extensively used outside the human body to. reduce wear of metals and to protect metals against

corrosion, In the automotive industry, ceramic surface engineering is used in bearings, brakes,
camshafts, cylinder heads, pistons and valve springs. Ceramic surface engineering is also used in aerospace, missile, machine tools, and constructive industry. During the surface engineering process, a ceramic is integrated into the metal surfaces by physical vapor deposition (PVD). The value of PYD technology lies in its ability to modify the surface properties of a device without changing the underlying material properties and biomechanical functionality. In addition to enhanced wear resistance, PYD coatings reduce friction, and are compatible with sterilization processes whilst increasing the materials resistance to corrosion, A unique hard-an-hard bearing hip prosthesis system was designed for Resurfacing Hip Arthroplasty (RHA) and conventional Total Hip Arthroplasty (THA) with large femoral head components (Fig. 10.1). The articulating surfaces of the metal (CoCrMo) components of this system after the normal production process were treated with ceramic surface engineering, using the ceramic titanium-niobium-nitride (TiNbN). After an extensive period of preclinical, mechanical and biological testing this system has been used in clinical practice from 2001 in THA, and from 2004 in RHA.

10.2 Purpose of the Study
The purpose of the study was to investigate whether the increase of the chromium and cobalt ion levels, which is normally seen in the blood of patients after MoM hip arthroplasty, can be prevented by using ceramic surface engineering components. Because in conventional THA metal ions are also generated at the cone and stem of the femoral components, the study of

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Fig.l0.1 Accis" Ceramic Surface Engineered components for total and resurfacing hip arthroplasty metal ions in patients after RHA (no femoral stem junction) was considered to be more appropriate to demonstrate the positive effect of ceramic surface engineering.

10.3 Materials and Methods
10.3.1 Patients
Unilateral resurfacing hip arthroplasty was carried out in 200 consecutive patients from three orthopaedic centres: Morriston Hospital Swansea UK, Nevill Hall Hospital Abergavenny UK and Arthro Clinic Hamburg Germany. The surgery was carried out by one single surgeon at each centre (DW, RR, and GB respectively). One-third of the total group were women and two-third were men. The mean age at the time of the operation was 55 years (34-72 years).

10.3.2 Materials In all patients the ACCIS® resurfacing hip hard-an-bard
metal components of the ACCIS® resurfacing bearing prosthesis, was used. The are made from a casted

hip prostheses

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chromium-cobalt-molybdenum (CoCrMo) alloy according to ISO 5832-4. After the casting phase, the components are cooled, heat treated, polished and undergo micro-surface finish. Different from the manufacture of MoM prostheses, after these treatments the articulating surfaces are then engineered with the ceramic titanium-niobium-nitride (TiNbN) by physical vapour deposition (PVD). The TiNbN is integrated into the articulating surfaces. The layer thickness is 0.3-0.9 J...Lm. ACCIS prostheses for total hip arthroplasty The (THA) and resurfacing hip arthroplasty (RHA) are manufactured by implantcast GmbH, Buxtehude, Germany. The ceramic surface engineering process is performed at DOT (Dunnschicht und Oberflachen Technik) in Rostock, Germany. The acetabular component is designed for press-fit cementless fixation with a triple-radius outside geometry with equatorial widening design and has a cementless backside coating of pure Titanium plasma spray (IPS) according to the ISO standard 5832-2.
Q

10.3.3

Methods
Blood samples of60 randomly selected patients with unilateral RHA, 20 from each centre, were taken and analyzed before surgery and at intervals of 3, 6, 12 and 24 months after surgery. Independent trace metal measurements were performed at the Universitatsklinikum Carl Gustav Carus, Dresden, Germany.

10.4

Results
The results showing "chromium and cobalt ion concentrations in the blood of patients after ACCISI!; RHA up to 2 years after surgery" are shown in Fig. 10.2. Pre- surgery the median chromium concentrations were 0.5 (0.25-2.8) and the median cobalt concentrations were 0.82 (0.075-2.86) ugr/L, The average chromium concentration was 0.589 and the average cobalt concentration was 0.903 ugr/L, The median chromium concentrations after 2 years were 0.94 (0.25-3.6) and the median cobalt concentrations after 2 years were ] .04 (0.07-2.36) ugr/L. The average chromium concentration after 2 years was 1.073 and the average cobalt concentration after 2 years was 1.095 J...Lgr/L. None 0 f the patten ts post operation has shown to have any apparent increase of Co and Cr ions in their blood, at 2 years' post-surgery.

10.5

Discussion
Metal ion measurement is a valuable tool for diagnosis and patient follow-up after MoM hip arthroplasty, Serum ion concentrations of cobalt and chromium can be used to estimate the amount of wear taking place in these devices [2]. Normal ion levels published in the

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10.00 9.00 8.00 7.00 6.00 5.00 4.00 3.00 2.00 1.00

pg/L

Chromium

Cobalt


..L.


iii
3m

o

T

Pre

.-•
Iii
1 yr


T
Pre 3m
1 yr

6m

2 yr

2 yr

-

Fig.10.2 Box plot showing metal ion data in ug/L, as published by MacDonald [8] The inferior, middle and superior horizontal lines of the boxes represent the first quartile, median and third quartile. The ends of the whiskers correspond to the limits of the data, beyond which values are considered anomalous. The mean is displayed with a~, outliers with a? and extreme outliers with an'. The light blue zone 0, 5-4 ug/L indicates the "normal" levels as described in the Handbook for Environmental Medicine

Table 10.1 Nanna I meta I ion levels in patients wi thout an implant [I 0] Serum Chromium Cobalt <1.0 ).lglL <3.9 ug/L Whole blood 05-4.0 ug/L 0.5~3.9 )lglL

Handbook of Environmental Medicine [10] are found to vary in whole blood from 0.5 to 4.0 for chromium and from 0.3 to 3,9 ugr/L : see Table 10. t. Serum cobalt and chromium measurements are generally higher in patients after MoM hip arthroplasty than in patients without a prosthesis. However, when measuring the metal ion levels, it is important to measure the levels before surgery first, because there are great differences between pre-surgery values of patients from different regions. In this study, differences were found between pre-surgery values of the patients from Wales and Hamburg. Witzleb [11] published much lower pre-operative metal ion levels in patients from Dresden, Germany. All measurements were performed in the same laboratory in Dresden: see Table 10.2. In this study of metal ion levels after RHA using a hard-an-hard surface engineered the first 2 years of post-surgery. Most wear in MoM prostheses prostheses with ceramic is usually seen during the bearing surfaces, the metal ion levels didn't show any change during

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Table 10.2 Varying pre-surgery metal

Ion

values

III

di fferent

areas

Cobalt Swansea (Wales UK) A bergavenny (UK) Hamburg (Germany) Dresden (Germany)
0.96 flg/L 0.81 ug/L 0.99 pg/L 0.50 ug/L

Chromium
1.87 ~lgIL 0.84 ug/L

1.31 ug/L
0.25 ~gIL

Table 103 Correlation between head size and mean meta I ion levels after 2 years Head size
42-44 mm 46-48111m

Chromium
1.26 ~lg/L (0.92-1.80) 0.63 ug/l. (0.25-0.94)

Cobalt 1.08 ug/L (0.90-1.18) 1.14 pg/L(0.62-1.59) 1.08 pgf_ (0.52-2.29)

>50mm

0.91 ug/l. (0.25-3.68)

mooing-in period between the first 500,000 and 2,000,000 million cycles of motion [5]. During this running-in phase, surface asperities formed by block-carbides are worn flat. After this period, wear of the articulating surfaces becomes minimal and corrosion of the articulating surfaces is the more important phenomenon. The absence of any increase in the metal ion levels is also in great contrast to the published data of other MoM prostheses. Because the ion level is believed to be a diagnostic tool to identify clinical complications, the absence of any increase of the metal ion levels demonstrates that wear of the ACCIS® Ceramic Surface Engineered components has been minimal. Corrosion does not occur as a result of the protection that ceramic surface engineering offers. The correlation between the mean metal ion levels, 2 years after the index operation, and femoral head size is summarized in Table 10.3. There was no difference in results between hips with smaller or larger femoral head size. The influence of cup position had not been measured in all patients, when this presentatioo was given at the EFORT Congress 2010. However, the mean metal ions were normal in seven patients with a steep position of the cup (five patients with more than 50° and two patients with more than 55° of abduction): chromium 1.64 (0.62-2.82 and cobalt 1.77 (0.62-4.59) ugr/L. Data about the cup position and metal ion levels in the blood of a greater cohort of patients after ACCIS® RHA will be published this year. The conclusion of this new study about the effect of cup position on blood metal ions is known already: in none of the cases with components placed in a less than optimal position an increase in Co and or Cr metal ion levels was demonstrated. Whilst malposition of the cup plays an important role in producing metallosis within the hip joint and increased metal ion levels in the blood of patients after MoM RHA without ceramic surface engineered surfaces, no change of metal ion levels was seen in patients with the ACCJS<It Ceramic Surface Engineered surface engineering corrosion, hard-on-hard bearing hip prosthesis. The ceramic against evidently minimizes wear and provides excellent protection

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10.6 Conclusion
Ceramic surface engineering of metal articulating surfaces of MoM hip prostheses effectively minimizes wear and corrosion and thus metal ion release. The absence of any increase of metal ion levels indicates that metal wear is minimal.

References
I. Australian Orthopaedic Register Yearbook (2008) 2. De Smet, K., De Haan, R., Calistri, A., Campbell, P.A., Ebrarnzadeh, E., Pattyn, c., GiB, H.S.: Metal ion measurement as a diagnostic tool to identify problems with metal-on-metal hip resurfacing. J. Bone Joint Surg, Am. 90(SuppI4), 202-208 (2008) 3. Dowson, D., Hardaker, c., Flett, M.,. Isaac, G.H.: A hip simulator study of the performance of metal-on-metal joints, Part I: the role of materials. J. Arthroplasty 19(8), 118~123 (2004) 4. Grammatopoulos, G., Pandit, H., Glyn-Jones, S., et al.: Optimal acetabular orientation for hip resurfacing. J. Bone Joint Surg. Br. 92(8), 1072-8 (20]0) 5. Isaac, G.H., Thompson, 1., Williams, S., Fisher, J.: Metal-on-metal bearing surfaces: materials, manufacture, design, optimization, and alternatives. Proc, lnst Mech ..Eng H J. Eng. Med. 220(2), ! 19-133 (2006)

6. lin, Z.M., Dowson, D., Fisher, 1.: Analysis of fluid film lubrication

7.

8..

9.

10.
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in artificial hip joint replacements with surfaces of high elastic modulus. Proe. Inst. Meeh. Eng. H. J. Eng. Med. 211(3),.247-256 (1996) Langton, D.J., Jameson, 5.S., Joyce, T.1., Webb, J., Nargol, A. v.. The effect of component size and orientation on the concentrations of metal ions after resurfacing arthroplastyof the hip. J. Bone Joint Surg. Br. 90(9),1143-51 (2008) MacDonald, S.l., Brodner, w., Jacobs, JJ.: A consensus paper on metal ions in metal-onmetal hip arthroplasties, J. Arthroplasty 19(5uppl 2), 12-16 (2004) Streicher, R.M., Serntitsch, M., Schon, R., Weber, H., Rieker, C.: Metal-on-metal articulation for artificial hip joints: laboratory study and clinical results .. Proc, Inst, Mech. Eng. H. 1. Eng. Med. 210(3), 223-232 (1996) Wichman, et al.: "Handbuch der Umweltmedizin"lSDN." 978-3-609-71180~5 (2007) Witzleb, w.c., Ziegler, J., Krumm enauer, F.. Neumeister, V., Guenther, K.P.: Exposure to , chromium, cobalt, molybdenum from metal-on-metal total hip replacement, hip resurfacing arthroplasty. Acta Orthop. 77(5), 697-705 (2006)

EFORT Reference in Orthopaedics and Traumatology Wolfhart Puhl . George Bentley· Klaus-Peter GUnther Tribology in Total Hip Arthroplasty Karl Knahr Editor

Series Editors

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